DOE 2000. - Waste Isolation Pilot Plant - U.S. Department of Energy

WIPP RH PSAR DOE/WIPP-03-3174 CHAPTER 9
9.3.3.2 Corrective Action Requests
Control of conditions adverse to quality, i.e., programmatic and/or process failures, malfunctions,
deficiencies, and nonconformances, is implemented in WP 13-QA3003, Corrective Actions Program. 14
Conditions adverse to quality are documented on Corrective Action Requests. All WTS personnel are
responsible for identifying and reporting conditions adverse to quality. Responsible management
investigates conditions adverse to quality and determines the corrective action response, including
remedial action, extent and impact of the condition, actions to prevent recurrence, and root cause, as
appropriate. The QA department verifies implementation of the corrective actions before the Corrective
Action Request is closed.
Significant conditions adverse to quality, as defined in the WTS QAPD 8 , are reported to and evaluated
by the QA department, relevant regulatory compliance functions, and the appropriate management
responsible for the condition, to determine if a work suspension order is necessary. If necessary, work is
suspended until the condition is corrected and verified by the QA department. Any WIPP employee
having a concern for employee safety, the safety of the environment, or the quality or regulatory
compliance of an activity has the responsibility and authority to suspend the performance of that activity.
9.3.3.3 Improvement Analysis
The WTS improvement analysis process is implemented in WP 13-QA3006, Data Analysis and
Trending. 15 WTS performs a periodic site evaluation and trend analysis of performance indicating data.
Performance data is identified, collected, and analyzed to identify adverse quality trends and
opportunities to improve items, activities, and processes. Results are reported to responsible
management and organizations responsible for corrective action.
9.3.4 Documents and Records
9.3.4.1 Documents
Document review, approval, issuance, and control requirements are delineated in the WTS QAPD 8 .
Documents which prescribe processes, specify requirements, or establish design are prepared, approved,
issued, and controlled in accordance with approved procedures. Documents are reviewed for adequacy,
correctness, and completeness, by designated technically competent reviewers, prior to approval and
issuance as controlled documents. The QA department reviews documents that translate QA
requirements into implementing documents, to ensure that QA program requirements are properly
implemented.
Document changes are indicated in the changed document and reviewed by the organizations or technical
disciplines affected. Editorial or minor changes may be made without the same level of review and
approval as the original or otherwise changed document.
The distribution and use of documents and forms is controlled. Documents used to perform work are
distributed to affected personnel and used at the work location. Effective dates are established for and
placed on approved documents. Controls are established and maintained to identify the current
status/revision of documents and forms. Obsolete or superseded documents and forms are controlled to
avoid their inadvertent use.
Implementation of the WTS procedures program is described in Chapter 8.
9.3-5 January 22, 2003